October 2, 2014
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NovoMix 30

(insulin aspart mix)

DIN (Drug Identification Number)

02265435 NOVOMIX 30 (PENFILL CARTRIDGE) SUSPENSION FOR INJ

What side effects are possible with NovoMix 30?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • redness, itching, or swelling at the site of the injection

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of low blood glucose:
    • anxiety
    • blurred vision
    • confusion
    • difficulty concentrating
    • difficulty speaking
    • dizziness
    • drowsiness
    • fast heartbeat
    • headache
    • hunger
    • nausea
    • nervousness
    • numbness or tingling of the lips, fingers, or tongue
    • sweating
    • tiredness
    • trembling
    • weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • rash or blisters all over the body
  • seizures
  • symptoms of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash)
  • unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for NovoMix 30?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: If you notice signs of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop taking the medication and seek immediate medical attention. Reactions at the site of injection (redness, swelling, and itching) usually resolve within a few days or weeks.

Appearance of insulin: The contents of the vial of this insulin should be cloudy and white. Do not use the insulin if it looks lumpy or grainy, seems unusually thick, sticks to the bottle or vial, or appears discoloured. Do not use it if it contains crystals, if the bottle or vial looks frosted, or if the suspension remains clear after being rolled between your hands.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

  • certain medical conditions (e.g., infections, thyroid conditions, or liver or kidney disease)
  • certain medications that increase or decrease blood glucose levels
  • diet
  • exercise
  • illness
  • injury
  • stress
  • surgery
  • travelling over time zones

It is important your doctor know your current health situation and any changes that may affect the amount of insulin you need. Blood glucose should be monitored regularly as recommended by your doctor or diabetes educator.

Diabetic identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue, lips, or fingers. Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks).

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.

Breast-feeding: Breast-feeding mothers may require adjustments in insulin dose or diet. It is not known if insulin aspart mix passes into breast milk. If you are a breast-feeding mother and are taking insulin aspart mix, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

What other drugs could interact with NovoMix 30?

There may be an interaction between insulin aspart mix and any of the following:

  • ACE inhibitors (e.g., ramipril, enalapril, lisinopril)
  • alcohol
  • anabolic steroids (e.g., testosterone)
  • beta-blockers (e.g., atenolol, metoprolol, pindolol, propranolol, sotalol)
  • birth control pills
  • certain diuretics (e.g., hydrochlorothiazide)
  • corticosteroids (e.g., prednisone, prednisolone)
  • danazol
  • decongestants (e.g., pseudoephedrine)
  • epinephrine
  • glucagon
  • glucocorticosteroids (e.g., prednisone, prednisolone)
  • growth hormone
  • lanreotide
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • octreotide
  • oral medications for diabetes (e.g., gliclazide, glyburide, pioglitazone, rosiglitazone)
  • phenytoin
  • salicylates (e.g., ASA)
  • sulfa antibiotics (e.g., sulfamethoxazole, sulfadiazine)
  • thyroid replacement therapy (if beginning or changing dose)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since alcohol, caffeine, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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